Trial results for a study investigating semaglutide tablets taken once daily for people with body weight above the healthy range were posted on ClinicalTrials.gov on 2026-02-25. The study showed that participants receiving oral semaglutide 25 mg achieved a mean body weight reduction of -14.4%, compared to -2.5% for those on placebo.
Background
The study, titled "Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range," aimed to evaluate the efficacy of semaglutide tablets as a treatment to help individuals living with overweight or obesity lose weight.
Trial design
The study (NCT05564117) was a Phase 3, randomized, placebo-controlled trial that enrolled 307 participants. The study investigated semaglutide tablets in people diagnosed with overweight or obesity. Participants were randomly assigned to receive either oral semaglutide 25 mg once daily or placebo once daily. The study lasted for 72 weeks, including a 1-week screening period, 64 weeks of treatment, and a 7-week follow-up period.
Key results
The trial results demonstrated significant differences in weight reduction between the oral semaglutide and placebo groups. For the outcome of "Percentage Change in Body Weight":
- Participants receiving oral semaglutide 25 mg achieved a mean body weight reduction of -14.4% (Standard Deviation: 10.5).
- Participants receiving placebo achieved a mean body weight reduction of -2.5% (Standard Deviation: 7.9).
A treatment difference analysis using ANCOVA showed a difference of -11.43 (95.0% CI: -13.88 to -8.98) with a p-value of 0.0001. A Mixed model for repeated measures (MMRM) analysis also showed a treatment difference of -13.87 (95.0% CI: -16.53 to -11.21) with a p-value of 0.0001.
Regarding the proportion of participants achieving specific weight loss thresholds:
- Weight loss ≥ 5%: 152 participants in the oral semaglutide 25 mg group achieved this, compared to 28 in the placebo group.
- Weight loss ≥ 10%: 121 participants in the oral semaglutide 25 mg group achieved this, compared to 13 in the placebo group.
- Weight loss ≥ 15%: 96 participants in the oral semaglutide 25 mg group achieved this, compared to 5 in the placebo group.
Logistic regression analysis for achieving weight loss ≥ 5% showed an Odds Ratio (OR) of 7.34 (95.0% CI: 4.22 to 12.76) with a p-value of 0.0001. For achieving weight loss ≥ 10%, the Odds Ratio was 25.23 (95.0% CI: 13.24 to 48.07) with a p-value of 0.0001.
What this means
The results from this Phase 3 trial indicate that oral semaglutide 25 mg significantly reduced body weight in individuals with overweight or obesity compared to placebo. The substantial mean percentage change in body weight and the higher proportion of participants achieving clinically meaningful weight loss thresholds (≥5%, ≥10%, ≥15%) suggest that oral semaglutide could be an effective therapeutic option for weight management in this population. These findings provide important data for clinicians considering treatment strategies for overweight and obesity.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05564117, titled "Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range," were posted on 2026-02-25 on clinicaltrials.gov.